Senior Medical Director, Oncology Clinical Development - GU

Senior Medical Director, Oncology Clinical Development - GU

Remote Type:
Hybrid (Remote & On-site)

Locations:
Baar Onyx, USA - MA
- Waltham, UK
- Hertfordshire
- Stevenage, USA - PA
- Upper Providence

The Senior Medical Director, Oncology Clinical Development - GU will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Sr. Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant internal scientific and medical leaders in order to lead clinical data generation activities.

This individual will also have a leading role in managing effective relationships with Key External Experts. This role requires an experienced professional capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

• Exhibit leadership at the program and cross-functional level and collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Oversee the development of high-quality protocols aligned with the Clinical Development Plan to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
• Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and medical data review.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK’s vision.
• Contribute to the clinical and technical diligence assessment of business development opportunities, as needed.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• Represent GSK at medical meetings, advisory boards and outreach meetings as needed/appropriate.
• Serv…